Nerve cuff

ABSTRACT

An electrode cuff includes a first elongate portion and a second elongate portion. The first elongate portion is configured to removably contact a length of a nerve while the second elongate portion extends outwardly at an angle relative to a first side edge of the first elongate portion to at least partially wrap about the nerve. The electrode cuff includes a first series of electrodes that is spaced apart longitudinally along the first elongate portion. A width of the second elongate portion is sized to fit between adjacent branches extending from a nerve.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 16/406,342, filed May 8, 2019, which is acontinuation application of U.S. patent application Ser. No. 14/595,771,filed Jan. 13, 2015, and now issued as U.S. Pat. No. 10,286,206, whichis a divisional application of U.S. patent application Ser. No.13/600,572, filed Aug. 31, 2012, and now issued as U.S. Pat. No.8,934,992, which claims the benefit of U.S. Patent Application No.61/530,002, entitled “Nerve Cuff,” filed Sep. 1, 2011, all of which areincorporated herein by reference.

BACKGROUND

A forced contraction of a muscle can be caused via electricalstimulation of a nerve that innervates the muscle. Typically, a powersource is coupled to the nerve via an electrical stimulation lead thatis, in turn, coupled to the nerve. For example, a distal end of anelectrical stimulation lead is formed as a cuff that can be securedabout the nerve to orient an electrically conductive portion of the leadin direct contact with the nerve. However, in many instances, thelocation in which a particular nerve resides presents significantchallenges in maneuvering the distal conductive portion of theelectrical lead into a target position relative to the nerve and insecuring the distal conductive portion in the target position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view schematically illustrating a nerveelectrode cuff system, according to an example of the presentdisclosure.

FIG. 1B is a diagram schematically illustrating an aspect of a nerveelectrode cuff system, according to an example of the presentdisclosure.

FIG. 2 is a top plan view schematically illustrating a nerve electrodecuff system, according to an example of the present disclosure.

FIG. 3 is a perspective view schematically illustrating a nerveelectrode cuff system, according to an example of the presentdisclosure.

FIG. 4 is a front plan view schematically illustrating an aspect ofimplanting a nerve electrode cuff system, according to an example of thepresent disclosure.

FIG. 5 is a front plan view schematically illustrating an aspect ofimplanting a nerve electrode cuff system, according to an example of thepresent disclosure.

FIG. 6 is a front plan view schematically illustrating an aspect ofimplanting a nerve electrode cuff system, according to an example of thepresent disclosure.

FIG. 7 is a front plan view schematically illustrating an aspect ofimplanting a nerve electrode cuff system, according to an example of thepresent disclosure.

FIG. 8 is a front plan view schematically illustrating an aspect ofimplanting a nerve electrode cuff system, according to an example of thepresent disclosure.

FIG. 9 is a front plan view schematically illustrating an aspect ofimplanting a nerve electrode cuff system, according to an example of thepresent disclosure.

FIG. 10 is a perspective view schematically illustrating a nerveelectrode cuff system, according to an example of the presentdisclosure.

FIG. 11 is a block diagram schematically illustrating a nervestimulation system, according to an example of the present disclosure.

FIG. 12 is a perspective view schematically illustrating a nerveelectrode cuff system, according to an example of the presentdisclosure.

FIG. 13 is a front plan view schematically illustrating a nerveelectrode cuff system, according to an example of the presentdisclosure.

FIGS. 14-15 are sectional views schematically illustrating a nerveelectrode cuff, according to an example of the present disclosure.

FIG. 16 is a sectional view schematically illustrating a nerve inrelation to application of a nerve electrode cuff system, according toan example of the present disclosure.

FIG. 17 is a top plan view schematically illustrating a nerve electrodecuff juxtaposed with a nerve, according to an example of the presentdisclosure.

FIG. 18 is a top plan view schematically illustrating a nerve electrodecuff, according to an example of the present disclosure.

FIG. 19 is a top plan view schematically illustrating a nerve electrodecuff, according to an example of the present disclosure.

FIG. 20 is a diagram, including a sectional view and a side view,schematically illustrating a nerve electrode cuff implanted relative toa nerve, according to an example of the present disclosure.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments of the present disclosure whichmay be practiced. In this regard, directional terminology, such as“top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is usedwith reference to the orientation of the Figure(s) being described.Because components of embodiments of the present disclosure can bepositioned in a number of different orientations, the directionalterminology is used for purposes of illustration and is in no waylimiting. It is to be understood that other embodiments may be utilizedand structural or logical changes may be made without departing from thescope of the present disclosure.

Embodiments of the present disclosure are directed to nerve cuffassemblies adapted for ease of use and for secure implantation of astimulation lead in a nerve stimulation system. In one embodiment, thesenerve cuff assemblies are adapted for use in implantation relative to ahypoglossal nerve as part of a system and method of treating sleepdisordered breathing, such as obstructive sleep apnea. In one aspect,these embodiments are configured to produce consistent, repeatablesurgical implantation and robust coupling to a nerve. In another aspect,these embodiments are configured for implantation on a more distalportion of a hypoglossal nerve in which, in some instances, the nervecuff will be located in proximity to one or more nerves branching offthe main trunk of the hypoglossal nerve. In this regard, the particularfeatures of the respective nerve cuff assemblies accommodate placementamong such nerve branches.

These embodiments, and additional embodiments, are described andillustrated in detail in association with FIGS. 1A-20 .

FIG. 1A is a perspective view schematically illustrating an electricallead 20, including a lead body 22 and a distal cuff portion 24,according to an embodiment of the present disclosure. In one embodiment,distal cuff portion 24 includes a spine portion 26 that extends fromlead body 22, and which supports a cuff body 32 defining a firstelongate portion. The cuff body 32 includes a distal end 28 and aproximal end 30 and a series of electrodes 34A, 34B, 34C extendingtherebetween to be spaced apart longitudinally along a length of thecuff body 32. In some embodiments, distal cuff portion 24 additionallyincludes a flap 40, defining a second elongate portion and having adistal end 42 (e.g. a tip) and a base 44 that extends from one side edge36 of cuff body 32. In one embodiment, flap 40 extends outwardly fromthe side edge 36 of cuff body 32 to form a generally acute angle (a)relative to side edge 36 of the cuff body 32, as shown in FIG. 1B. Inone embodiment, the angle (a) can fall within a range of about 10 toabout 80 degrees, and in other embodiments, the angle (a) falls within arange of about 30 to about 60 degrees. In some embodiments, the angle(a) falls within a range of about 40 to about 50 degrees. In oneembodiment, the angle (a) is about 45 degrees. In one aspect, the angle(a) is selected to orient the flap 40 to be interposed between twoadjacent nerve branches and to wrap in contact about cuff body 32, aswill be further shown in FIGS. 4-5 . In another aspect, base 44 of flap40 is positioned at a proximal end 30 of cuff body 32 so that distalportion 42 is oriented toward distal end 28 of cuff body 32.

It will be understood that in other embodiments, base 44 of flap 40 canbe attached to distal end 28 of cuff body 32 so that flap 40 extendstoward proximal end 30 of cuff body at an angle (a). In other words, theflap 40 would extend in direction opposite that shown in FIG. 1A.

FIG. 2 is a side plan view further schematically illustrating the lead20 of FIG. 1 . In one example, as shown in FIG. 2 , two outer electrodes34A, 34C are spaced apart from each other along a length of the cuffbody 32 by a distance D1 and each electrode (e.g. electrode 34B) has awidth (D2). In one example, the width W1 of the flap 40 (FIG. 1A) isgenerally equal to or greater than the width (D2) of the centralelectrode 34B but the width (W1) of flap 40 is less than the distance ofseparation (D1) between the two outer electrodes 34A, 34C. In thisarrangement, flap 40 exhibits a narrow profile for fitting betweenadjacent nerve branches 104, 106, as depicted in at least FIGS. 4-5 .

In some examples, the width W1 of flap 40 is twice the width (D2) of oneof the respective electrodes (e.g. electrode 34B). In other examples,the width W1 of flap 40 is three times the width (D2) of one of therespective electrodes (e.g. electrode 34B). In one aspect, by makingflap 40 generally wider than a respective electrode (e.g. electrode 34B)a sufficient overlap of the flap 40 relative to the electrode (e.g.electrode 34B) is obtained.

FIG. 3 is a perspective view schematically illustrating a lead 50 havingsubstantially the same features and attributes as lead 20 (FIG. 1 ),except with side edge 35 of cuff body 32 including a notched portion 52,according to an embodiment of the present disclosure. In one embodiment,the notched portion 52 begins at the distal end 28 and, in someembodiments, extends a distance (X) that is about one-quarter toone-third of a length (L1) of the cuff body 32, as shown in FIG. 3 . Thenotched portion 52 is positioned and sized to permit a distal portion 42of flap 40 to extend within notched portion 52 upon flap 42 beingwrapped around a nerve (as shown in FIGS. 4-5 ) so that flap 40 retainsa smaller profile when fully secured about nerve.

In other embodiments, notched portion 52 is located at a midportion ofcuff body 32 or located at a proximal end 30, such as the previouslymentioned embodiment in which a flap 40 would extend from a distal end28 of the cuff body toward the proximal end 30.

In one embodiment, flap 40 is biased in a curled shape approximating theouter circumference of a nerve so that when flap 40 is released (frombeing held via forceps or other means), flap 40 automatically wrapsabout the nerve and distal portion 42 automatically falls within notchportion 52 of cuff body 32. In another aspect, notched portion 52 issized and positioned based on the angle (a) at which flap 40 extends(FIG. 1B) to ensure that distal portion 42 of flap 40 aligns withnotched portion 52.

FIG. 4 is a diagram 100 schematically illustrating implantation of anelectrode cuff 124 about a nerve 102, according to an embodiment of thepresent disclosure. In one embodiment, electrode cuff 124 includessubstantially the same features and attributes as electrode lead 20(FIGS. 1-3 ) with similar reference numerals referring to similarelements. It will be understood that a lead body, such as lead body 22,extending proximally from cuff 124 but is not shown for illustrativepurposes.

As shown in FIG. 4 , upon partial implantation, the cuff body 132 liesunderneath nerve 102 and is positioned along a length of nerve 102 sothat flap 140, when wrapped about nerve 102 (as represented bydirectional arrow F), will pass through the gap G between branch nerves104, 106. In one embodiment, flap 140 has width (W1 in FIG. 1 ) lessthan a width of the gap (represented by length L2 in FIG. 4 ) betweenthe branch nerves 104, 106. In one embodiment, the width (W1) of flap140 is substantially less than a length (L1 in FIG. 4 ) of the cuff body132. In one embodiment, the electrodes 134A, 134B, 134C provide atripolar arrangement with a negative electrode (e.g. cathode) interposedbetween two positive electrodes (e.g. anodes), although it will beunderstood that other electrode configurations can be used. As shown inFIG. 4 , the target zone for stimulation is generally represented by themarker “X” shown along nerve 102. Accordingly, when the target zone forstimulation of the nerve falls within an area encroached by branchnerves 104, 106, the nerve cuff 124 is especially suited to beingsecured relative to nerve 102 despite the presence of the branch nerves104, 106 adjacent the target zone (represented by X). In particular, therelatively narrow width of flap 40 enables its positioning betweenbranch nerves 104, 106 while the angle (a) at which flap 40 extends fromthe proximal end 130 of the cuff body 132 further facilitatesinterposing the flap 40 between branch nerves 104, 160 and theself-wrapping behavior of flap 40 about cuff body 132 and nerve 102.

In one example, as shown in FIG. 4 , two outer electrodes 134A, 134C arespaced apart from each other along a length of the cuff body 132 by adistance D1 and each electrode (e.g. electrode 134B) has a width (D2).In one example, the width W1 of the flap 140 (such as W1 of flap 40 inFIG. 1A) is generally equal to or greater than the width (D2) of thecentral electrode 134B but width (W1) is less than the distance ofseparation (D1) between the two outer electrodes 134A, 134C. In thisarrangement, flap 140 exhibits a narrow profile for fitting betweenadjacent nerve branches 104, 106.

In some examples, the width W1 of flap 140 is twice the width (D2) ofone of the respective electrodes (e.g. electrode 134B). In otherexamples, the width W1 of flap 140 is three times the width (D2) of oneof the respective electrodes (e.g. electrode 134B).

As shown in FIG. 5 , upon guiding flap 140 through gap G and thenpermitting flap 40 to wrap itself about cuff body 132, the cuff body 132becomes releasably secured about nerve 102. Moreover, because flap 140straddles the gap G between the two branch nerves 104, 106, the cuffbody 132 is further restrained from longitudinal movement along thelength of nerve 102.

As apparent from FIG. 5 , in one example flap 140 defines a firstelongate portion having a length sufficient to extend from one side edgeof the cuff body 132, encircle the nerve, and overlap at least a portionof the opposite side edge of the cuff body 132.

FIG. 6 is a diagram 150 including a side plan view schematicallyillustrating implantation of an electrode cuff 154 about a nerve 102,according to an embodiment of the present disclosure. As shown in FIG. 6, flap 170 includes a base 174 mounted to or extending from a midportion161 (intermediate between distal end 158 and proximal end 160) of cuffbody 162. Accordingly, with cuff body 162 positioned along a length ofnerve 102 to place electrodes 164 at a desired target portion of nerve102, flap 170 is sized with a width (W2) configured to be interposedbetween branch nerves 104, 106. However, unlike the angled flap 40 (FIG.1-5 ), flap 170 extends generally perpendicular to the longitudinal axisof the cuff body 162. FIG. 7 schematically illustrates the arrangementupon flap 170 being wrapped about nerve 102 and the cuff body 162 tosecure electrode cuff 154 about nerve 102. Accordingly, the embodimentof FIGS. 6-7 includes substantially the same features and attributes asthe embodiment of FIGS. 1-5 , except for flap 170 being mounted relativeto a midportion 161 of cuff body 162 and for flap 170 being generallyperpendicular to cuff body 162.

In one example, as shown in FIG. 6 , two outer electrodes 164A, 164C arespaced apart from each other along a length of the cuff body 162 by adistance D1 and each electrode (e.g. electrode 164B) has a width (D2).In one example, the width W2 of the flap 170 is generally equal to orgreater than the width (D2) of the central electrode 164B but width (W2)is less than the distance of separation (D1) between the two outerelectrodes 164A, 164C. In this arrangement, flap 170 exhibits a narrowprofile for fitting between adjacent nerve branches 104, 106.

In some examples, the width W1 of flap 170 is twice the width (D2) ofone of the respective electrodes (e.g. electrode 164B). In otherexamples, the width W1 of flap 170 is three times the width (D2) of oneof the respective electrodes (e.g. electrode 164B). In one aspect, bymaking flap 170 generally wider than a respective electrode (e.g.electrode 164B) a sufficient overlap of the flap 170 relative to theelectrode (e.g. electrode 164B) is obtained.

FIG. 8 is a diagram schematically illustrating an electrode cuff 184being implanted about nerve 102 using flap 200, according to anembodiment of the present disclosure. Electrode cuff 184 includessubstantially the same features and attributes as electrode cuff 154 aspreviously described in association with FIGS. 6-7 , except with flap200 having a tapered shape. As shown in FIG. 8 , like flap 170 ofelectrode cuff 154 of FIG. 6 , flap 200 of electrode cuff 184 has a base204 mounted at a midportion 191 of cuff body 192. However, unlike thegenerally straight flap 170, flap 190 includes a butterfly-type shape inwhich a waist portion 203 of flap 200 is substantially narrower than thebase 204 and/or the distal portion 202 of flap 200. In one aspect, waistportion 203 has a width (W3) substantially less than a width (W4) of thedistal portion 202 or base 204 of flap 190. In one embodiment, waistportion 203 is at an intermediate location between the distal portion202 and base portion 204. In one aspect, width (W3) of waist portion 203is less than distance (gap G) between the branch nerves 104, 106. In oneembodiment, distal portion 202 and base portion 204 have a width (W4)that is substantially less than a length (L1) of cuff body 192.

In one aspect, by making the distal portion 202 and the base portion 204substantially wider than the waist portion 203, the flap 200 has asubstantially greater surface area in contact with nerve 102 and withcuff body 192 as flap 200 wraps around those structures, which in turn,increases the holding strength the flap 190 relative to thosestructures. In addition, in another aspect, by providing generally widerportions 202 and 204 of flap 200 on opposite sides of the gap (G)between the branch nerves 104, 106, and sizing the waist portion 203 tofit between branch nerves 104, 106, the electrode cuff 184 becomes moresecurely anchored along the length of the nerve 102 (less likely toslide) and becomes more resistant to shifting/twisting.

In other embodiments, width (W4) of distal portion 202 and/or baseportion 204 is generally equal to a length (L1) of cuff body 132 evenwhile the waist portion 193 has width (W3) that remains sized to fit inthe gap G between branch nerves 104, 106.

In one example, as shown in FIG. 8 , two outer electrodes 194A, 194C arespaced apart from each other along a length of the cuff body 192 by adistance D1 and each electrode (e.g. electrode 194B) has a width (D2).In one example, the width W3 of the narrower waist portion 203 of flap200 is generally equal to or greater than the width (D2) of the centralelectrode 194B but width (W3) is less than the distance of separation(D1) between the two outer electrodes 194A, 194C. In this arrangement,narrower waist portion 203 of flap 200 exhibits a narrow profile forfitting between adjacent nerve branches 104, 106.

In some examples, the width W3 of waist portion 203 is twice the width(D2) of one of the respective electrodes (e.g. electrode 194B). In otherexamples, the width W3 of waist portion 203 is three times the width(D2) of one of the respective electrodes (e.g. electrode 194B). In oneaspect, by making flap 200 generally wider than a respective electrode(e.g. electrode 194B) a sufficient overlap of the flap 200 relative tothe electrode (e.g. electrode 194B) is obtained.

FIG. 9 is diagram including a side plan view schematically illustratingthe flap 200 of cuff 184 of FIG. 8 when completely wrapped about thecuff body 192 and nerve 102.

FIG. 10 is a perspective view schematically illustrating an electrodelead 220, according to an embodiment of the present disclosure. As shownin FIG. 10 , electrode lead 220 includes a lead body 222 and anelectrode cuff 224. The cuff 224 includes cuff body 225 having a shortflap portion 226 on a first side 228 and a long flap portion 230 on asecond opposite side 232 of the cuff body 225. In one aspect, the longflap portion 230 is substantially longer (in a direction generallyperpendicular to a longitudinal axis of the lead body 202) than theshort flap portion 226. In addition, an elongate strap 240 extends froma side edge 245 of the long flap portion 230. The elongate strap 240 issized and positioned to help guide the long flap portion 230 behind anerve during surgery. In one embodiment, elongate strap 240 has a width(W5) that is substantially less than a length of long flap portion 230and of the cuff body 225 in general.

FIG. 11 is a diagram 300 schematically illustrating a stimulation system300, according to an embodiment of the present disclosure. As shown inFIG. 11 , system 300 includes an implantable cuff module 310 and anexternal support module 312. The implantable cuff module 310 includes acuff 320, an antenna 322, and an integrated circuit 324. In oneembodiment, cuff 320 includes any one of the cuff designs describedwithin the present disclosure as well as other cuff designs. In oneembodiment, the antenna 322 comprises a radiofrequency (RF) antenna forperforming wireless communication with a reciprocating antenna orcircuitry.

The external support module 312 includes an external antenna 330(external to the body in which cuff module 310 is implanted),microcontroller 332, memory and programming element 334, sensor array336, and power unit 338.

The external antenna 330 is equipped to perform wireless communicationvia RF waves or using other wireless communication protocols.Microcontroller 332 directs operation of the cuff module 310 and variouscomponents of the support module 312. Memory and programming element 334stores a therapy regimen and stimulation control profiles for electrodecuff 322. Sensor array 336 includes one or more sensors placed andconfigured to detect physiologic parameters relating to respiration andgeneral indicators of health in order to detect obstructed breathingpatterns and/or whether or not an efficacious response has occurred as aresult of therapy applied via system 300. In some embodiments, thesensors 336 sense information regarding acoustic parameters,position/posture of a patient, heart rate, bioimpedance, bloodoxygenation, respiratory rate, inspiratory and expiratory phases, etc.

In one embodiment, as represented by dashed lines 344, the componentsand elements of external support module 312 are housed in one or morecontaining elements. In some embodiments, the containing elementsinclude one or more of a garment 360, pillow 362, bed 364, and headband366. In one aspect, the garment 360 includes one or more of a shirt,pants, necklace, wristband, and/or sleeve or other article that can beworn on the body and is constructed to house one or more of the elementsof the external support module 312 in relatively close proximity to theimplanted cuff module 310 to enable wireless communication between thecuff module 310 and the external support module 312. In one aspect, byhousing power unit 338 in garment 360, the patient avoids having a powerunit implanted in their body. The garment 360 is sized and shaped sothat when the patient is sleeping while wearing garment 360, the powerunit 338 becomes positioned in sufficiently close proximity to theimplanted cuff module 310 to ensure proper communication andtransmission of power to the cuff module 310.

FIG. 12 is perspective view schematically illustrating a lead system380, according to an embodiment of the present disclosure, in which leadbody 380 includes an anchor portion 382 secured to a nearby tendon orbody structure, such as the digastric tendon 386. In one embodiment,anchor portion 382 forms a coiled or pigtail shape configured toautomatically wrap itself about the tendon 386. In this way, cuff 390becomes more securely attached in the vicinity of its implantation abouta nerve 386. In one embodiment, the anchor portion 382 is implemented ona freestanding cuff module, such as cuff 390 in FIG. 12 or cuff module310 in FIG. 11 . In other embodiments, the anchor portion 382 isdeployed on a full length lead that extends from a cuff module to animplanted pulse generator or controller.

FIG. 13 is a diagram 450 including a top plan view schematicallyillustrating an electrode cuff 460 aligned for deployment on a nerve462, according to an embodiment of the present disclosure. The electrodecuff 460 includes a first end 470, a second end 472 with an array 480 ofelectrodes 481 aligned along a portion of cuff 460. As shown in FIG. 13, in one embodiment, the array 480 of electrodes 481 includes a firstanode 484, a cathode 486, and second anode 488 with cathode 486interposed between the respective anodes 484, 488.

In general terms, the electrode cuff 460 is configured for mounting onnerve 102 so that a longitudinal axis of the electrode array 480 isaligned generally perpendicular to a longitudinal axis of nerve 102 inthe vicinity at which cuff 460 is deployed. In other words, instead ofaligning a series of electrodes to extend along a length of nerve 102,the cuff 460 is sized and configured so that the series of electrodesextend circumferentially about a nerve and generally perpendicular to alongitudinal axis of the nerve 102.

In one embodiment, the electrode cuff 460 has a width (W6) and a length(L2) with length (L2) being substantially greater than width (W6). Inone aspect, width (W6) is at least one-half the length (L2) with thewidth (W6) sized to fit between branch nerves (such as branch nerves104, 106 in FIG. 4 ). Accordingly, electrode cuff 460 is suited fordeployment in more distal regions of nerve and/or in regions in whichtight spacing exists between adjacent branches from a nerve.

In one example, as shown in FIG. 13 , electrodes 481 have a width (D2)and the width W6 of the cuff 460 is generally equal to or greater thanthe width (D2) of the electrodes 481. In some examples, the width W6 ofcuff 460 is about twice the width (D2) of the electrodes 481. In otherexamples, the width W6 of cuff 460 is about three times the width (D2)of each electrode 481. In these arrangements, cuff 460 exhibits a narrowprofile for fitting between adjacent nerve branches (such as nervebranches 104, 106 shown in FIGS. 4-5 ).

FIG. 14 is a sectional view of an elongate electrode cuff (such as cuff460 in FIG. 13 ) deployed about a nerve 501, according to an embodimentof the disclosure. As shown in FIG. 14 , with the array 480 ofelectrodes positioned about the circumference of the nerve 102 and uponapplying an electrical stimulation signal to the nerve 501 via cuff 460,an energy field (represented by E within the boundaries 504 and 506)exerted upon nerve 501, which thereby causes firing of various fascicleswithin nerve 501 (as represented by region 502).

FIG. 15 is sectional view an elongate electrode cuff (such as cuff 460in FIG. 13 ) deployed about a nerve 501, according to an embodiment ofthe disclosure. However, in this embodiment, a portion 511 of theelectrode cuff 460 extends generally outward from the rest of the cuff460 to orient additional electrodes at a spaced distance from the nerveand the other electrodes (488, 486) that are in contact with the nerve.In this arrangement, a controller is used to select whether electrode484, 512, 514 is activated and depending upon which electrode 484, 512,514 is activated, a different shape and size energy field will act onthe nerve. In general terms, because the electrodes 512, 514 are spacedapart from the nerve 501, the energy field is expanded and stretchedupon activation of one of those remotely located electrodes. As shown inFIG. 15 , upon activation of electrode 484 along with electrodes (488,486), the energy field takes the shape and size represented by region502 as shown in FIGS. 14 and 15 . However, if electrode 512 is activatedinstead of electrode 484, then one boundary of the energy field movesfrom dashed line A to B, and the resulting energy field takes on thesize and shape depicted as the sum of regions 502 and 503 in FIG. 16 .Similarly, if electrode 514 were activated instead of electrodes 484 or512, then the energy field would be further expanded in size toward the“right” side of the nerve with the new boundary defined by dashed lineC, shown in FIG. 15 .

In one embodiment, cuff 410 is deployed so that the extended portion 511extends toward a surface of the body.

In one aspect, the electrode cuff 460 is particularly adapted formounting transversely to longitudinal axis of the nerve at the targetstimulation location to fit between adjacent branch nerves. In addition,when additional electrodes such as electrodes 512 and 514 areincorporated into the cuff 410, an operator can selectively modify ashape and size of the energy field applied to a cross-section of thenerve to achieve the targeted stimulation.

FIG. 17 is a diagram 520 schematically illustrating an electrode lead521 being mounted relative to a nerve, according to an embodiment of thepresent disclosure. As shown in FIG. 17 , electrode lead 521 includes anelectrode portion 522, a transverse portion 523, and a body portion 524.A longitudinal axis of the electrode portion 522 extends generallyparallel to a longitudinal axis of the body portion 524. Meanwhile, thetransverse portion 523 is interposed between, extends generallyperpendicular to, the respective electrode and body portions 522, 524.

The electrode portion 522 includes an array of electrodes 530 aligned inseries. The transverse portion 523 has length (L3) sufficient to extendabout at least one-third to one-half of a circumference of the nerve andhas a width (W8) sized to fit between adjacent branch nerves 527, 529(see also 104, 106 in FIG. 3 ). In one aspect, branch nerves 527, 529are spaced apart by a distance D3.

In one aspect, the transverse portion 523 is biased to self wrappartially about the circumference of the nerve which in turn aligns theelectrode portion 522 generally parallel to a longitudinal axis of thenerve and for contact with the nerve in that alignment. Similarly, thetransverse alignment of the transverse portion 523 also aligns bodyportion to extend alongside the nerve and to be further secured thereto.

FIG. 18 is a top plan view of an electrode cuff 550, according to anembodiment of the present disclosure. As shown in FIG. 18 , electrodecuff 550 includes an electrode portion 552 and a body portion 554 fromwhich the electrode portion 552 extends. The electrode portion 552 has afirst electrode portion 557 and a second electrode portion 558. Thefirst electrode portion 557 supports an array 560 including electrodes562, 564, and 566 while the second electrode portion 558 supports asecond electrode array 570 including electrodes 572, 574, and electrode566. Accordingly, electrode 566 serves in both electrode arrays 560, 570depending upon which electrode array 560, 570 is activated (or if bothelectrode arrays 560, 570 are activated). In another aspect, firstelectrode portion 557 (and its electrode array 560) extends generallyperpendicular to second electrode portion 558 (and its electrode array570). The first electrode portion 557 is sized and positioned foralignment generally parallel to a longitudinal axis of a nerve while thesecond electrode portion is sized and position for alignment transverseto the longitudinal axis of the nerve. In one embodiment, either thefirst end portion 559A or the second end portion 559B of the secondelectrode portion 558 is aligned to extend at least partiallycircumferentially about the nerve, such as between two adjacent branchnerves (such as branch nerves 527, 529 in FIG. 17 ). In another aspect,the second end portion 559B of second electrode portion 558 extendsbetween the first electrode portion 557 and the body portion 554.

In one embodiment, second electrode portion 558 is sized and biased toself-wrap at least partially about a circumference of the nerve, whichin turn aligns first electrode portion 557 to be generally parallel to alongitudinal axis of the nerve and for contact with the nerve in thatalignment.

In one example, second electrode portion 558 has a width (W10) sized tofit between adjacent branch nerves 527, 529 (FIG. 17 ). Accordingly, thewidth W10 is less than the distance D3 between the adjacent nervebranches 527, 529. In one example, the width W10 is at least twice thewidth (or diameter) D4 of each electrode 566, 572, 574 and less than thedistance D3. In another example, the width W10 is at least three timesthe width (or diameter) D4 of each electrode 566, 572, 574 and less thanthe distance D3.

FIG. 19 is a top plan view of an electrode cuff 600, according to anembodiment of the present disclosure. As shown in FIG. 18 , electrodecuff 600 includes an electrode portion 610 and a body portion 614 fromwhich the electrode portion 612 extends. The electrode portion 612 has afirst electrode portion 617 and a second electrode portion 618. Thefirst electrode portion 617 supports an array 620 including electrodes622, 624, and 626 while the second electrode portion 618 supports asecond electrode array 630 including electrodes 632, 634, 636 andelectrode 626. Accordingly, electrode 626 serves in both electrodearrays depending upon which electrode array 620, 630 is activated (or ifboth electrode arrays 620, 630 are activated). In another aspect, firstelectrode portion 617 (and its electrode array 620) extends generallyperpendicular to second electrode portion 618 (and its electrode array630) with the respective first and second electrode portions 617, 618forming a cross shape with electrode 626 in the center of the cross. Thefirst electrode portion 617 is sized and positioned for alignmentgenerally parallel to a longitudinal axis of a nerve while the secondelectrode portion 618 is sized and position for alignment transverse tothe longitudinal axis of the nerve. In one embodiment, either the firstend portion 619A or the second end portion 619B of the second electrodeportion 618 is aligned to extend at least partially circumferentiallyabout the nerve, such as between two adjacent branch nerves (such asbranch nerves 527, 529 in FIG. 17 ).

In this arrangement, the second electrode portion 618 is sized andshaped to be interposed between a pair of adjacent branch nerves (suchas nerves 104, 106 in FIGS. 4-5 ) and/or to fit between or among otherstructures surrounding the nerve, thereby ensuring quick and robustimplantation of nerve cuff 610 about the nerve.

Moreover, second electrode portion 618 is biased to self-wrap at leastpartially about a circumference of the nerve, which in turn alignssecond electrode portion 617 to be generally parallel to a longitudinalaxis of the nerve and for contact with the nerve in that alignment. Atthe same time, the self-wrapping properties of second electrode portion618 places the electrodes of array 630 in contact with the nerve.

In one embodiment, second electrode portion 618 has length (L4)sufficient to extend about at least one-third to one-half of acircumference of the nerve and in some embodiments, second electrodeportion 618 has a length (L4) to extend substantially completely aboutan entire circumference of the nerve.

FIG. 20 is a diagram 650 that schematically illustrates a sectional view(a) and a side view of a nerve (b) when electrode cuff 610 is deployedon a nerve, according to an embodiment of the present disclosure. Asshown in FIG. 20 , electrodes 632, 634, 626, 636 generally encircle andcontact the nerve 601 while electrodes 622, 626, 624 extend along thelength of and contact the nerve 601. In this way, the electrode cuff 610is positioned to apply a stimulation signal using the second electrodearray 630 (electrodes 632, 634, 626, 636) or the first electrode array620 (electrodes 622, 626, 624) or some combination of some of theelectrodes of the two different arrays 620, 630. In this latterarrangement, during an implantation and testing phase, a controller isused to determine which combination of electrodes produces the mostefficacious stimulation signal and going forward, that combination ofelectrodes is used to apply the therapeutic treatment. Of course, itwill be understood that via the controller, additional adjustmentsregarding the selection of active electrodes can be made afterimplantation and after some period of treatment.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present disclosure. This application isintended to cover any adaptations or variations of the specificembodiments discussed herein.

What is claimed is:
 1. An electrode system comprising: an electrode cuffcomprising: a cuff body transitionable to a deployed state about anerve, the cuff body defining: a first portion having a circumferentialarrangement about a centerline in the deployed state, a second portionextending from the first portion, including the second portionprojecting away from the centerline in the deployed state; at least onefirst electrode carried by the first portion; and at least one secondelectrode carried by the second portion.
 2. The electrode system ofclaim 1, wherein the at least one first electrode is arranged relativeto the first portion to contact the nerve in the deployed state.
 3. Theelectrode system of claim 2, wherein the at least one second electrodeis arranged relative to the first portion to not contact the nerve inthe deployed state.
 4. The electrode system of claim 2, wherein the atleast one second electrode is spaced apart from the nerve in thedeployed state.
 5. The electrode system of claim 1, wherein the secondportion projects radially relative to the centerline in the deployedstate.
 6. The electrode system of claim 1, wherein the second portionextends perpendicularly relative to the circumferential arrangement inthe deployed state.
 7. The electrode system of claim 1, wherein firstportion is configured to wrap about the nerve in the deployed state. 8.The electrode system of claim 1, wherein the first portion is at leastpartially self-wrappable about the nerve.
 9. The electrode system ofclaim 1, wherein the first portion is biased to, and has a lengthsufficient to, releasably encircle the nerve.
 10. The electrode systemof claim 1, wherein the at least one first electrode includes aplurality of first electrodes.
 11. The electrode system of claim 10,wherein the plurality of first electrodes defines an electrode array,and further wherein the electrode array is arranged perpendicular to thecenterline.
 12. The electrode system of claim 1, wherein the at leastone second electrode includes a plurality of second electrodes.
 13. Theelectrode system of claim 1, wherein the at least one first electrodeincludes a plurality of selectively activatable first electrodes, andfurther wherein the at least one second electrode includes a pluralityof selectively activatable second electrodes.
 14. The electrode systemof claim 1, further comprising: a controller to send control signals tothe at least one first electrode and the at least one second electrode.15. The electrode system of claim 14, wherein the controller is locatedexternal to a patient's body.
 16. The electrode system of claim 14,wherein the at least one first electrode includes a plurality of firstelectrodes, and further wherein the at least one second electrodeincludes a plurality of second electrodes, and further wherein thecontroller is operable to activate selective ones of the firstelectrodes and the second electrodes to generate differently-shaped anddifferently-sized energy fields.
 17. The electrode system of claim 14,wherein the at least one second electrode is operated by the controlleras a stimulation electrode.
 18. The electrode system of claim 1, furthercomprising: a wireless communication portion, associated with at leastone of the cuff body, the first electrode, and the second electrode, toreceive control signals from an external controller to selectivelyactivate at least one of the first electrode and the second electrode.19. The electrode system of claim 18, wherein the wireless communicationportion includes an antenna and circuitry.